Antimicrobial ResistanceNCT06436690
Optimizing Antibiotics Prescription
A study testing Diagnosis Mandate and Individualized Feedback in people with Antimicrobial Resistance, run by Penn State University at 2 sites in 2 countries.
Trial summary
Interventions that are low-cost, do not add substantially to the physician workload, are consistent with good physician practices and WHO guidelines, and serve as a reminder on the risks of overprescribing antibiotics are critically needed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antimicrobial Resistance
- What is being tested?
- Diagnosis Mandate and Individualized Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Apr 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18+
- working at an outpatient clinic in one of the participating hospitals.
- age 18+
- sought care at one of the outpatient clinics in the participating hospitals.
Who cannot join
- <18 years of age
- working at more than one of the participating hospitals
- For patients:
- <18 years of age
- one of the vulnerable populations (pregnant women, cognitively impaired adults)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Pennsylvania State University
University Park, Pennsylvania, 16801
Nepal1 site
Institute for Social and Environmental Research - Nepal
Bharatpur, Bagmati, 44200
About this study
Official title: Optimizing Antibiotics Prescription: A Stepped-Wedge Randomized Trial
Interventions that are low-cost, do not add substantially to the physician workload, are consistent with good physician practices and WHO guidelines, and serve as a reminder on the risks of overprescribing antibiotics are critically needed. The overall goal of the proposed project is to test the effect of two behavioral interventions targeted to junior physicians-specifically, requiring them to specify the diagnosis in the prescription note and providing feedback-on their antibiotics prescription rate; examine the intervention's effects across gender and caste; and draw lessons for scaling up the intervention.
Read the detailed description
Antimicrobial resistance (AMR) is one of the top ten threats to global health. Limited existing evidence from Nepal, the site for the proposed study, suggests that physicians "err on the side of caution" by prescribing antibiotics even for viral conditions, which contributes to AMR. Interventions that are low-cost, do not add substantially to the physician workload, are consistent with good physician practices and WHO guidelines, and serve as a reminder on the risks of overprescribing antibiotics are critically needed. The overall goal of the proposed project is to test the effect of a behavioral intervention targeted to junior physicians-specifically, requiring them to specify the diagnosis in the prescription note and providing feedback-on their antibiotics prescription rate; examine the intervention's effects across gender and caste; and draw lessons for scaling up the intervention.
The specific objectives are the following:
Objective 1. Assess the effect of a behavioral intervention targeted to junior physicians on antibiotics prescription rate, including by caste and gender of the patient. A stepped-wedge randomized control trial (RCT) will be conducted among 60 junior physicians in five hospitals (1 government, 2 private teaching, and 2 community) in Nepal. The intervention will be rolled out sequentially across the hospitals and data will be collected from patients (n=3,600) both before and after the intervention. The intervention will consist of three components: (a) a Refresher Training on AMR, (b) a Diagnosis Mandate, and (c) an Individualized Feedback.
Objective 2. Identify barriers to scaling up the intervention beyond the study's site and strategies for their mitigation. After preliminary analysis of the quantitative data, key informant interviews with national- and provincial- level health policy makers (n=5), and in-depth interviews with physicians (n=5) and hospital managers (n=5) will be conducted.
Objective 3. Assess the extent to which physicians prescribe antibiotics correctly. From a subset of patients (n=120, i.e., 2 per physician), more detailed medical information will be collected and analyzed from their outpatient booklet.
This registration is for objective 1. Therefore, only details pertaining to that objective will be provided here.
- Conditions
- Antimicrobial Resistance
- Being tested
- Diagnosis Mandate, Individualized Feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis MandateBehavioural
The intervention consists of: a) a Refresher Training on AMR, and (b) a Diagnosis Mandate.
Individualized FeedbackBehavioural
Physicians receive a customized feedback on their prescription behavior, including antibiotics prescription rate.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | During this phase, physicians do not receive any intervention. |
| Diagnosis Mandate | Experimental | In this phase, physicians receive a refresher training on AMR and a letter requiring the physicians to specify the diagnosis in their prescription note. Receives: Behavioral: Diagnosis Mandate |
| Feedback | Experimental | In this phase, physicians receive a customized feedback letter on their prescription behavior, including antibiotics prescription rate. Receives: Behavioral: Individualized Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotics prescription rate
The number of patient visits in which antibiotics are prescribed by the total number of visits
Measured: 1-3 months before the intervention and 3-5 months after the intervention, depending on the timing of the intervention which varies by hospital.
Secondary outcomes (2)
Differences in prescription rates by patient's gender
The number of patient visits in which antibiotics are prescribed by the total number of visits, by male and female
Measured: 1-3 months before the intervention and 3-5 months after the intervention, depending on the timing of the intervention which varies by hospital.
Differences in prescription rates by patient's ethnicity (advantaged versus disadvantaged)
The number of patient visits in which antibiotics are prescribed by the total number of visits, by advantaged and disadvantaged status
Measured: 1-3 months before the intervention and 3-5 months after the intervention, depending on the timing of the intervention which varies by hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start15 Apr 2025
- Primary completion28 Nov 2025
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antimicrobial ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a stepped-wedge randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yubraj Acharya, Ph.D., Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436690
- Sponsor's protocol ID
- STUDY00025143
- Status last verified
- Nov 2025
- First submitted
- 24 May 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are potential risks about confidentiality, as the number of physicians is small.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Antibiotics Prescription: A Stepped-Wedge Randomized Trial
- ClinicalTrials.gov ID
- NCT06436690
- Acronym / sponsor ID
- STUDY00025143
- Conditions
- Antimicrobial Resistance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Interventions that are low-cost, do not add substantially to the physician workload, are consistent with good physician practices and WHO guidelines, and serve as a reminder on the risks of overprescribing antibiotics are critically needed. The overall goal of the proposed project is to test the effect of two behavioral interventions targeted to junior physicians-specifically, requiring them to specify the diagnosis in the prescription note and providing feedback-on their antibiotics prescription rate; examine the intervention's effects across gender and caste; and draw lessons for scaling up the intervention.
Detailed description
Antimicrobial resistance (AMR) is one of the top ten threats to global health. Limited existing evidence from Nepal, the site for the proposed study, suggests that physicians "err on the side of caution" by prescribing antibiotics even for viral conditions, which contributes to AMR. Interventions that are low-cost, do not add substantially to the physician workload, are consistent with good physician practices and WHO guidelines, and serve as a reminder on the risks of overprescribing antibiotics are critically needed. The overall goal of the proposed project is to test the effect of a behavioral intervention targeted to junior physicians-specifically, requiring them to specify the diagnosis in the prescription note and providing feedback-on their antibiotics prescription rate; examine the intervention's effects across gender and caste; and draw lessons for scaling up the intervention.
The specific objectives are the following:
Objective 1. Assess the effect of a behavioral intervention targeted to junior physicians on antibiotics prescription rate, including by caste and gender of the patient. A stepped-wedge randomized control trial (RCT) will be conducted among 60 junior physicians in five hospitals (1 government, 2 private teaching, and 2 community) in Nepal. The intervention will be rolled out sequentially across the hospitals and data will be collected from patients (n=3,600) both before and after the intervention. The intervention will consist of three components: (a) a Refresher Training on AMR, (b) a Diagnosis Mandate, and (c) an Individualized Feedback.
Objective 2. Identify barriers to scaling up the intervention beyond the study's site and strategies for their mitigation. After preliminary analysis of the quantitative data, key informant interviews with national- and provincial- level health policy makers (n=5), and in-depth interviews with physicians (n=5) and hospital managers (n=5) will be conducted.
Objective 3. Assess the extent to which physicians prescribe antibiotics correctly. From a subset of patients (n=120, i.e., 2 per physician), more detailed medical information will be collected and analyzed from their outpatient booklet.
This registration is for objective 1. Therefore, only details pertaining to that objective will be provided here.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- This is a stepped-wedge randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –During this phase, physicians do not receive any intervention. |
| Diagnosis Mandate | Experimental | Behavioral: Diagnosis MandateIn this phase, physicians receive a refresher training on AMR and a letter requiring the physicians to specify the diagnosis in their prescription note. |
| Feedback | Experimental | Behavioral: Individualized FeedbackIn this phase, physicians receive a customized feedback letter on their prescription behavior, including antibiotics prescription rate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18+
- working at an outpatient clinic in one of the participating hospitals.
- age 18+
- sought care at one of the outpatient clinics in the participating hospitals.
Key exclusion criteria (5 listed)
- <18 years of age
- working at more than one of the participating hospitals
- <18 years of age
- one of the vulnerable populations (pregnant women, cognitively impaired adults)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnosis MandateThe intervention consists of: a) a Refresher Training on AMR, and (b) a Diagnosis Mandate. | Behavioural | Diagnosis Mandate |
| Individualized FeedbackPhysicians receive a customized feedback on their prescription behavior, including antibiotics prescription rate. | Behavioural | Feedback |
Primary outcome
Antibiotics prescription rate
Time frame: 1-3 months before the intervention and 3-5 months after the intervention, depending on the timing of the intervention which varies by hospital.
The number of patient visits in which antibiotics are prescribed by the total number of visits
2 secondary outcomes
Differences in prescription rates by patient's gender
Time frame: 1-3 months before the intervention and 3-5 months after the intervention, depending on the timing of the intervention which varies by hospital.
Differences in prescription rates by patient's ethnicity (advantaged versus disadvantaged)
Time frame: 1-3 months before the intervention and 3-5 months after the intervention, depending on the timing of the intervention which varies by hospital.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No. There are potential risks about confidentiality, as the number of physicians is small.
Related trials for Antimicrobial Resistance
Not yet recruitingObservational study
Antimicrobial Resistance and Genomic Profiling of Bacterial Isolates
Blood Stream Infections, Adult Cancer Patients
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
RecruitingObservational study
Immunosuppression and Intensive Care Unit-acquired Multidrug-resistant Bacteria
Critically-ill Patients
Active, not recruitingObservational study
Antibiotic Resistance Genes in Periodontitis
Periodontal Disease, Periodontitis
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnosis Mandate and Individualized Feedback in people with Antimicrobial Resistance, run by Penn State University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiotics prescription rate (time frame: 1-3 months before the intervention and 3-5 months after the intervention, depending on the timing of the intervention which varies by hospital.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.